Drug Registration and Acceptance

Drug Name

Exact

Active Ingredient

Acceptance No.

Manufacturers

Acceptance Date

Status Date

Classification

Review Status

Drug Type

Submission

Evaluation Conclusion

ATC Category

Special Approval Varieties

Task Type

Major Special Varieties

Sequence No.

Stock Code

Visualized Analysis Export Evaluation Conclusion Evaluation Progress

Acceptance No.	Drug Name	Active Ingredient	Dosage Form	Classification	Submission	Acceptance Date	Manufacturers	Manufacturers	Review Status	Status Date	View
CXSL2300015	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products(3.3)	New Drug Application	2023-01-06		Nanjing Zhengda Tianqing Pharmaceutical Co Ltd			view
CXSL2500356	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products(3.3)	New Drug Application	2025-05-08		Nanjing Zhengda Tianqing Pharmaceutical Co Ltd			view
CXSL2500357	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products(3.3)	New Drug Application	2025-05-08		Nanjing Zhengda Tianqing Pharmaceutical Co Ltd			view
JXSS2000012	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Import Drug Application	2020-05-23	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;Roche Pharma (Schweiz) AG;Chugai Pharma Manufacturing Co Ltd	In Review	2021-03-30	view
JXSS2000013	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Import Drug Application	2020-05-23	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;Roche Pharma (Schweiz) AG;Chugai Pharma Manufacturing Co Ltd	In Review	2021-03-30	view
JXSS2000014	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Import Drug Application	2020-05-23	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;Roche Pharma (Schweiz) AG;Chugai Pharma Manufacturing Co Ltd	In Review	2021-03-30	view
JXSS2000015	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Import Drug Application	2020-05-23	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;Roche Pharma (Schweiz) AG;Chugai Pharma Manufacturing Co Ltd	In Review	2021-03-30	view
JYSB1900128	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Supplementary Application	2019-06-19	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd	Certificate Issued	2019-10-17	view
JYSB1900129	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Supplementary Application	2019-06-19	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd	Certificate Issued	2019-10-17	view
JYSB1900130	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Supplementary Application	2019-06-19	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd	Certificate Issued	2019-10-17	view
JYSB1900131	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Supplementary Application	2019-06-19	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd	Certificate Issued	2019-10-17	view
JYSB1900196	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Supplementary Application	2019-08-07	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd	In Review	2019-08-06	view
JYSB1900197	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Supplementary Application	2019-08-07	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd	In Review	2019-08-06	view
JYSB1900198	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Supplementary Application	2019-08-07	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd	In Review	2019-08-06	view
JYSB1900199	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Supplementary Application	2019-08-07	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd	In Review	2019-08-06	view
JYSB1900333	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Supplementary Application	2019-12-04	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd	Certificate Issued	2020-01-22	view
JYSB1900334	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Supplementary Application	2019-12-04	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd	Certificate Issued	2020-01-22	view
JYSB1900335	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Supplementary Application	2019-12-04	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd	Certificate Issued	2020-01-22	view
JYSB1900336	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Supplementary Application	2019-12-04	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd	Certificate Issued	2020-01-22	view
JYSB2000080	艾美赛珠单抗注射液	emicizumab	Injection	Biological Products	Supplementary Application	2020-03-25	罗氏（中国）投资有限公司	Roche (China) Holding Ltd;F Hoffmann-La Roche Ltd(Switzerland);Chugai Pharma Manufacturing Co Ltd	Certificate Issued	2020-06-10	view